Endometriosis Trial: Study of NBI-56418 in Endometriosis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00109512
First received: April 28, 2005
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up continued every 4 weeks for 12 weeks.


Condition Intervention Phase
Endometriosis
Drug: NBI-56418 (GnRH antagonist)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.


Secondary Outcome Measures:
  • Endometriosis Health Profile-5 (EHP-5) [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    The EHP-5 assesses quality of life.

  • Visual Analog Scale (VAS) scores [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    VAS measures endometriosis pain.

  • Number of Subjects with Adverse Events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Laboratory Tests [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Vital Sign Measurements [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Physical Examinations [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) tracings [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: April 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
Experimental: NBI-56418 75 mg Drug: NBI-56418 (GnRH antagonist)
Experimental: NBI-56418 150 mg Drug: NBI-56418 (GnRH antagonist)

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Be female, aged 18 to 49 years, inclusive.
  • Have pelvic pain and dysmenorrhea resulting in a Composite Pelvic Sign and Symptoms Score (CPSSS) of ≥ 6.
  • Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within the last 5 years of the start of screening.
  • Have regular menstrual cycles (28 days ±5 days) for greater than or equal to 2 years. For the cycle that immediately precedes dosing, cycle length will be determined as part of the medical history.
  • Have a Body Mass Index between 18 and 30 kg/m2.
  • Agree to use two forms of non-hormonal contraception (unless sterilized by tubal ligation) for greater than or equal to 3 months prior to Screening through ovulation and return of menses after treatment.
  • Have a negative serum pregnancy test at Screening and a negative urine pregnancy test at prior to dosing at the beginning of Week 1.
  • Have a cervical smear negative for malignancy at Screening.
  • Be willing to comply with all study procedures and restrictions.
  • Be able to read, understand, and sign the ICF (informed consent form) before entering into the study.
  • Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA).

Exclusion Criteria

  • Are currently receiving a GnRH agonist or GnRH antagonist, or have received any of these agents within 6 months of Screening.
  • Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
  • Are currently receiving hormonal therapy including the oral contraceptive pill or have received any of these agents within 3 months of Screening.
  • Are on any concurrent medical treatment/medications or have had surgical or hormonal treatment other than oral contraceptives for endometriosis within 3 months of Screening.
  • Have uterine fibroids or any other pelvic lesions greater than or equal to 3 cm in diameter as verified by ultrasound.
  • Are currently breast-feeding an infant.
  • Are using any steroid preparation, taken by any route (e.g., oral, inhaled) on a chronic or regular basis within 3 months of Screening.
  • Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study outcomes.
  • Have chronic pelvic pain that is not caused by endometriosis.
  • Have any psychological disorder according to criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders, 4th edition within one year before screening. Such disorders include, but are not limited to, alcohol and substance abuse/dependence.
  • Have a history of poor compliance in clinical research studies.
  • Have a medically significant illness in the 30 days before the beginning of Week 1.
  • Have a medically significant abnormality observed upon Screening or the beginning of Week 1 physical examination, or in any other baseline measurement. Findings outside the standard reference ranges will be jointly approved with NBI's (Neurocrine Biosciences) Medical Monitor before being considered eligible for the study.
  • Are using any investigational drug within 2 months of Screening.
  • Have a positive human immunodeficiency virus antibody (HIV Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) assay at Screening or have a history of a positive result.
  • Have an allergy, hypersensitivity, or intolerance to a GnRH agonist or antagonist.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109512

Locations
United States, Arizona
Site Reference ID/Investigator# 56266
Phoenix, Arizona, United States, 85032
United States, California
Site Reference ID/Investigator# 55210
San Diego, California, United States, 92103
Site Reference ID/Investigator# 55214
San Ramon, California, United States, 94566
United States, Florida
Site Reference ID/Investigator# 56267
Clearwater, Florida, United States, 33759
United States, Illinois
Site Reference ID/Investigator# 56270
Champaign, Illinois, United States, 61820
Site Reference ID/Investigator# 56273
Chicago, Illinois, United States, 60612
Site Reference ID/Investigator# 56269
Oak Brook, Illinois, United States, 60523
Site Reference ID/Investigator# 56271
Peoria, Illinois, United States, 61615
United States, Kentucky
Site Reference ID/Investigator# 56272
Louisville, Kentucky, United States, 40291
United States, North Carolina
Site Reference ID/Investigator# 55213
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Site Reference ID/Investigator# 55211
Arlington, Texas, United States, 76012
United States, Utah
Site Reference ID/Investigator# 56268
Sandy, Utah, United States, 84070
United States, Virginia
Site Reference ID/Investigator# 56274
Richmond, Virginia, United States, 23294
Site Reference ID/Investigator# 55212
Virginia Beach, Virginia, United States, 23451
United States, Washington
Site Reference ID/Investigator# 56275
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Williams, MD Abbott
  More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT00109512     History of Changes
Other Study ID Numbers: NBI-56418-0501
Study First Received: April 28, 2005
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
endometriosis
pelvic pain
painful periods
dysmenorrhea
painful menstruation
GnRH
agonist
antagonist
menstrual pain

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 27, 2014